cyclosporine ophthalmic (Rx)

Brand and Other Names:Restasis, Cequa, more...Verkazia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strength

ophthalmic emulsion

  • 0.05% (Restasis; single-use or multidose vials)

ophthalmic solution

  • 0.09% (Cequa; single-use vial)

Keratoconjunctivitis Sicca

Cequa, Restasis

Indicated to increase tear production associated with keratoconjunctivitis sicca (dry eye)

Instill 1 drop BID in each eye ~12 hr apart

If using single-dose vial, discard immediately after using in both eyes

Vernal Keratoconjunctivitis

Verkazia only

Indicated for vernal keratoconjunctivitis (VKC) in children and adults

Instill 1 drop QID (morning, noon, afternoon, and evening) into affected eye(s)

May discontinue treatment once signs and symptoms have resolved

If recurs, treatment may be reinitiated

Corneal Melting (Orphan)

Orphan designation for use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer

Orphan sponsor

  • Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Prevention of Graft Rejection

Orphan designation for treatment of patients at high risk of graft rejection following penetrating keratoplasty

Orphan sponsor

  • Orphan sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Keratoconjunctivitis

Orphan designation for treatment of herpes simplex virus stromal keratitis

Orphan sponsor

  • NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Keratoconjunctivitis Sicca

Orphan designation for treatment of severe keratoconjunctivitis sicca associated with Sjögren's syndrome

Orphan sponsor

  • University Of Georgia; College of Veterinary Medicine, Department of Small Animal Medicine; Athens, GA 30602

Corneal Graft Rejection

Orphan designation for prevention of corneal graft rejection

Orphan sponsor

  • NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Dosing Considerations

Restasis

  • Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctual plugs
  • Not studied in patients with history of herpes keratitis

Dosage Forms & Strength

ophthalmic emulsion

  • 0.05% (Restasis; single-use or multidose vials)
  • 0.1% (Verkazia; single-dose vial)

Keratoconjunctivitis Sicca

Restasis only

<16 years: Not studied

≥16 years

  • Indicated to increase tear production associated with keratoconjunctivitis sicca (dry eye)
  • Instill 1 drop BID in each eye ~12 hr apart
  • If using single-dose vial, discard immediately after using in both eyes

Vernal Keratoconjunctivitis

Verkazia only

≥4 years

  • Indicated for vernal keratoconjunctivitis (VKC) in children and adults
  • Instill 1 drop QID (morning, noon, afternoon, and evening) into each affected eye
  • May discontinue treatment once signs and symptoms have resolved
  • If recurs, treatment may be reinitiated

Dosing Considerations

Restasis

  • Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctual plugs
  • Not studied in patients with a history of herpes keratitis
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Adverse Effects

>10%

Verkazia

  • Eye pain (12%)

1-10%

Restasis

  • 1-5%
    • Conjunctival hyperemia
    • Discharge
    • Epiphora
    • Eye pain
    • Foreign body sensation
    • Stinging
    • Visual disturbance (eg, blurring)

Verkazia

  • Eye pruritus (8%)
  • Ocular discomfort (6%)
  • Visual acuity reduced (5%)
  • Cough (5%)
  • Ocular hyperemia (4%)
  • Headache (4%)
  • Upper respiratory tract infection (2%)

Postmarketing Reports

Hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea)

Superficial injury of the eye (from the vial tip touching the eye during administration)

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Warnings

Contraindications

Known or suspected hypersensitivity to any of the ingredients in the formulation

Cautions

Remove contact lenses prior to administration

Do not touch eyelids with vial tip to avoid contamination

Do not use with contact lenses; lenses may be reinserted 15 minutes following administration ophthalmic emulsion/solution

Patients with decreased tear production typically should not wear contact lenses

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies of administration in pregnant females to inform a drug-associated risk

Infertility

  • No data are available on drug effects on human fertility
  • No impairment of fertility reported in animals receiving intravenous cyclosporine

Animal data

  • Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses
  • Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations; doses (normalized to body weight) were ~320 times higher than the daily maximum recommended human ophthalmic dose of 0.015 mg/kg/day

Lactation

There is no information regarding drug presence in human milk following topical administration or on effects on breastfed infants and milk production

Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Cequa and Restasis

  • Exact mechanism of action is not known
  • Calcineurin inhibitor; immunosuppressive agent when administered systemically
  • In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eyes, cyclosporine emulsion is thought to act as a partial immunomodulator

Verkazia

  • Exact mechanism of action for VKC is unknown
  • Following ocular administration, cyclosporine is believed to act by blocking the release of pro-inflammatory cytokines (eg, IL-2)

Absorption

Verkazia

  • Peak plasma concentration: 0.67 ng/mL

Cequa

  • Blood concentrations (for multiple doses): Either not detectable or marginally above the lower limit of assay quantitation of 0.100 ng/mL (range 0.101- 0.195 ng/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple dose

Restasis

  • Drug accumulation: Not detectable after 12 months of treatment
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Administration

Ophthalmic Administration

Ophthalmic use only

Single-use solution or emulsion: After opening for administration to one or both eyes use immediately, and discard remaining contents immediately

Do not administer while wearing contact lenses; remove contacts prior to administration; contacts may reinsert 15 minutes following administration

Restasis

  • Invert vial a few times to obtain uniform, white, opaque emulsion before use
  • May be used concomitantly with artificial tears, allowing a 15-minute interval between products

Verkazia

  • Gently shake the single-dose vial several times to obtain a uniform, white, opaque
  • emulsion before use
  • Missed dose: Continue treatment as normal, at the next scheduled administration
  • Multiple topical ophthalmic products being use
    • Eye drops: Administer eye drops at least 10 minutes apart to avoid diluting products
    • Eye ointment, gel, or other viscous eye drops: Administer Verkazia 10 minutes before administration

Storage

After opening the aluminum pouch, keep the single-dose vial in the pouch to protect from light and avoid evaporation

Discard any opened individual single-dose vial with any remaining emulsion immediately after use

Do NOT freeze

Emulsion: Store at 15-25°C (59-77°F)

Solution: Store at 20-25°C (68-77°F); store single-use vials in the original foil pouch

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Sandimmune oral
-
100 mg capsule
Sandimmune oral
-
25 mg capsule
Sandimmune oral
-
100 mg/mL solution
Restasis ophthalmic (eye)
-
0.05 % liquid
Restasis ophthalmic (eye)
-
0.05 % liquid
Sandimmune intravenous
-
250 mg/5 mL solution
cyclosporine oral
-
25 mg capsule
cyclosporine oral
-
100 mg capsule
Restasis MultiDose ophthalmic (eye)
-
0.05 % drops
cyclosporine intravenous
-
250 mg/5 mL solution
cyclosporine intravenous
-
250 mg/5 mL solution
cyclosporine intravenous
-
250 mg/5 mL solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
cyclosporine ophthalmic (eye)

CYCLOSPORINE - OPHTHALMIC

(SYE-kloe-SPOR-in)

COMMON BRAND NAME(S): Cequa, Restasis

USES: Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

HOW TO USE: Read the Instructions for Use if available from your pharmacist before you start using cyclosporine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication in the affected eye(s) as directed by your doctor, usually twice a day (about 12 hours apart).To apply eye drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.There are different brands of this medication available. Some brands should be mixed before use. If your brand does not need to be mixed before use, the liquid is clear and colorless. If your brand should be mixed, evenly mix the eye drops by turning the vial upside down a few times before using your dose. The mixed drops should look milky and white. Ask your doctor or pharmacist if you have any questions about your brand.If you have dry eyes, contact lens wear is usually not recommended. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. If directed to use this medication in both eyes, repeat these steps for your other eye. Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 15 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Wait several minutes for your vision to clear before driving or operating machinery.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.If you are using the single-use form of this medication, throw away the opened vial after use. Do not save for later use.Tell your doctor if your condition gets worse.

SIDE EFFECTS: Eye discomfort/redness/itching, feeling as if something is in the eye, or temporary blurred vision may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent eye infection.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Code Definition
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.